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journal of dentistry 39 (2011) 341–350

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Review

Acupuncture for treating temporomandibular joint disorders:


A systematic review and meta-analysis of randomized,
sham-controlled trials

Aram Jung a, Byung-Cheul Shin a,*, Myeong Soo Lee b, Hoseob Sim a, Edzard Ernst c
a
School of Korean Medicine, Pusan National University, Yangsan, South Korea
b
Brain Disease Research Centre, Korea Institute of Oriental Medicine, Daejeon, South Korea
c
Complementary Medicine, Peninsula Medical School, Universities of Exeter, Exeter, UK

article info abstract

Article history: Objective: The aim of this article was to assess the clinical evidence for or against acupunc-
Received 31 October 2010 ture and acupuncture-like therapies as treatments for temporomandibular joint disorder
Received in revised form (TMD).
13 February 2011 Data: This systematic review includes randomized clinical trials (RCTs) of acupuncture as a
Accepted 21 February 2011 treatment for TMD compared to sham acupuncture. The search terms were selected
according to medical subject heading (MeSH).
Sources: Systematic searches were conducted in 13 electronic databases up to July 2010;
Keywords: Medline, PubMed, The Cochrane Library 2010 (Issue 7), CINAHL, EMBASE, seven Korean
Acupuncture Medical Databases and a Chinese Medical Database.
Temporomandibular joint disorder Study selection: All parallel or cross-over RCTs of acupuncture for TMD were searched
Pain without language restrictions. Studies in which no clinical data and complex interventions
Systematic review were excluded. Finally, total of 7 RCTs met our inclusion criteria.
Meta-analysis Conclusions: In conclusion, our systematic review and meta-analysis demonstrate that the
evidence for acupuncture as a symptomatic treatment of TMD is limited. Further rigorous
studies are, however, required to establish beyond doubt whether acupuncture has thera-
peutic value for this indication.
# 2011 Elsevier Ltd. All rights reserved.

women than men.4,5 Its aetiology regards as multi-factorial,


1. Introduction structure-related, and controversial.2
Current medical interventions for the management of TMD
A temporomandibular joint disorder (TMD) is clinically consist of jaw-appliance therapy, medications, physiotherapy,
characterized by pain and dysfunction in the masticatory home self-care and surgery.1 Noninvasive, nonsurgical thera-
muscles or temporomandibular joint (TMJ).1 TMDs are most pies are most commonly used for TMD.6 Though there is
common form of chronic orofacial pain.2 The prevalence of controversy exists in reporting whether they were successful
TMD in the U.S.A. is between 40% and 75%.2,3 TMD is common for TMD treatments to date,6 however, clinical research and
in adults aged 20–50 years, and it is more prevalent amongst experience have been reported TMD is successfully managed

* Corresponding author at: Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan 626-870,
Kyungnam, South Korea. Tel.: +82 51 510 8482; fax: +82 51 510 8420.
E-mail addresses: drshinbc@gmail.com, drshinbc@pusan.ac.kr (B.-C. Shin).
0300-5712/$ – see front matter # 2011 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jdent.2011.02.006
342 journal of dentistry 39 (2011) 341–350

by one or another of current modalities once the correct der or TMD or Jaw disease or Craniomandibular disease or
diagnosis and proper management are provided.7 {(myofascial pain) or (myofascial pain dysfunction) and TMD}]
A survey showed that 74% of TMD patients used comple- and [acupuncture or Acup* or moxibustion or acupressure or
mentary and alternative medicine (CAM) therapies. Most of ‘‘laser acupuncture’’ or ‘‘auricular acupuncture’’] in English,
the respondents reported being most satisfied with the ‘‘hands Chinese and Korean. We selected these terms according to
on’’ CAM therapies such as massage or acupuncture.8 medical subject heading (MeSH). In addition, the references in
Acupuncture has been claimed to be effective in TMD all located articles were manually searched for further
treatments in the mechanism of pain reduction, anti- relevant articles.
inflammation, and neurohormonal effects.9,10
In acupuncture clinical research, it is difficult to draw a 2.2. Study selection
reliable conclusion due to lack of appropriate placebo.11 Of
various placebo controls, ‘‘sham’’ procedure can be defined as 2.2.1. Types of studies
one performed on a control group to ensure that they have the This review included parallel or cross-over RCTs that assessed
same experiences like real group subjects do.11 Furthermore, the efficacy of acupuncture regardless of blinding, language
several recent studies reported sham acupuncture interven- and type of reporting. Studies in which no clinical data were
tion is more relevance method than other physical placebos reported were excluded. We also excluded complex interven-
due to the effect of excluded psychological effect.12,13 In one tions in which acupuncture was not a sole treatment.
neurologic study based on brain-imaging analysis, the Dissertations and abstracts were included, if provided they
psychological responses to placebo analgesia were similar contained sufficient detail.
to those that were elicited by the administration of ‘‘real’’
analgesic substances.14 Therefore, a sham control method is 2.2.2. Types of patients
more rigorous than other controls for identifying the specific This study included subjects with TMD that was diagnosed by
effects of acupuncture especially in pain. any defined or specified diagnosis criteria, regardless of their
Up to recently, four systematic reviews of acupuncture for age, race and gender. The conditions of patients in the
TMD are available.15–18 However, one review was out of date16 included RCTs were classified into articular-, muscular or the
and secondly published one reviewed 4 sham controlled two types combined of TMD. Studies in which patients were
randomized clinical trials (RCTs) without comprehensive reported as having pain or functional symptoms in the jaw
meta-analysis.17 The third one reviewed 19 RCTs (including muscle, temples, face, pre-auricular area, or in the ear were
5 sham controlled) without meta-analysis15 and the last included. Our study excluded patients with TMD found to be
published one did 9 RCTs (including 4 sham controlled) with caused by psychogenic, neurologic and metabolic disorders.
meta-analysis.18 All did not conduct full searches because
three of them restricted their searches only in English.16–18 2.2.3. Types of interventions
Consequently, all were missing the important sham controlled Acupuncture is defined as the stimulation of acupuncture
RCTs.19–21 In addition, none adopted subgroup analysis and points or trigger points by needles that pierce the skin, or by
sensitivity analysis of meta-analysis which were strictly heating the mugwort herb (moxibustion) in combination with
recommended by PRISMA guideline.22 Thus, their conclusions needles, or by electrical stimulation.23 Methods of stimulating
are unsafe, even can be biased. acupuncture points that do not involve needle insertion (e.g.,
Therefore, the aims of our review were to critically evaluate laser, acupressure, moxibustion) are also included in this
the totality of the most rigorous clinical evidence for or against review. We included only sham acupuncture (such as
the effectiveness of acupuncture-type treatments compared penetrating or non-penetrating sham needle, non-activated
to relevant sham one in patients with TMD and to provide a laser acupuncture) as controls.
comprehensive PRISMA-compliant systematic review with
sensitivity and subgroup analysis. 2.2.4. Outcome measures
One of the following outcome measures was required for
inclusion: pain intensity or pain relief in TMJ measured by
2. Methods visual analogue scale (VAS), verbal scale, or algometer. Other
clinically important outcomes included measured maximum
2.1. Data sources inter-incisal mouth opening (MO), or range of motion (ROM) of
TMJ, or response rate (responder vs. non-responder).
The following electronic databases were searched from their
inceptions up to July 2010: Medline, PubMed, The Cochrane 2.2.5. Data extraction and quality assessment
Library 2010 (Issue 7), CINAHL, EMBASE, seven Korean Medical Copies of all articles of RCTs were obtained and read in full. All
Databases (DBPIA, OASIS, Korea Institute of Science and articles were read by two independent reviewers (ARJ, BCS)
Technology Information, National Assembly Library, Korean and data from the articles were validated and extracted
Studies Information, The Journal of Korean Acupuncture and according to pre-defined criteria.24 Quality assessment was
Moxibustion Society, The Korean Journal of Meridian and assessed using the Cochrane risk of bias criteria. The quality of
Acupoint) and a Chinese Medical Database (China Academic the RCTs was addressed as follows amongst 6 domains: (1)
Journal, www.cnki.co.kr). Was the allocation sequence adequately generated? (2) Was
The search phrases used were [temporomandibular or allocation adequately concealed? (3) Was knowledge of the
temporomandibular joint or Temporomandibular joint disor- allocated intervention adequately prevented during the study?
journal of dentistry 39 (2011) 341–350 343

(4) Were incomplete outcome data adequately addressed? (5) calculated using Cochrane Collaboration software [Review
Are reports of the study free of suggestion of selective outcome Manager 5 (RevMan) Version 5.0.25 for Windows. Copenhagen:
reporting? (6) Was the study apparently free of other problems The Nordic Cochrane Centre]. The variance of the change was
that could put it at a high risk of bias? As practitioner blinding imputed using a correlation factor of 0.5 as suggested by the
may not be possible due to the nature of acupuncture, patient Cochrane Collaboration.25 We then pooled data across studies
blinding was assumed for cases in which the control using random effect models if excessive statistical heteroge-
intervention was indistinguishable from acupuncture, even neity did not exist. The chi-square test and the Higgins I2 test
if the word ‘blinding’ did not occur in the report. The point for were used to assess heterogeneity.26 For more comprehensive
evaluator blinding was only given if specified in the text. We understanding of meta-analysis or if any kinds of heteroge-
resolved any disagreements by referring to the trial report and neity exist, we conducted subgroup analysis or sensitivity
through discussion between reviewers (ARJ, BCS) and if analysis additionally. Publication bias was assessed by funnel-
needed, by seeking the opinion of a third reviewer (MSL). plot using the Cochrane software.

2.3. Data synthesis 2.4. Statistical analysis

To summarize the effects of acupuncture on each outcome, we To estimate sample size, we set the mean with standard
abstracted the risk estimates (relative risk: RR) for dichoto- deviation from the difference of VAS between real and sham
mous data and standardized mean difference (SMD) for groups. Sample size was estimated by 80% power (0.2 in beta
continuous data with 95% confidence interval (CI). RR or error) and 0.05 alpha error by using SigmaPlot software for
[()TD$FIG]SMD or weight mean difference (WMD) with 95% CI were Windows Version 11.0 (Systat Softwere Inc., San Jose, CA, U.S.A.).

Publications identified (n=491)

Publications excluded after screening the abstract


and title (n =398). Reasons:
Not related to acupuncture (n=52)
Not related to TMD (n=111)
Not clinical studies (n=117)
Animal studies (n=11)
Case series (n=38)
Case reports (n=69)

Articles further evaluated by full text (n =93)

Excluded (n=34)
UCTs (n=18)
NRCTs (n=16)

RCT but excluded, because of (n=52)


Mixed treatments (n=18)
Not TMD patients (n=1)
Duplication (n=5)
Compared with another type of acupuncture
(n=4)
Compared with other active therapies
(n=23)
(6 trials originated from 2 trials, finally
n=19, summarized in Supplement 1)
Sham controlled but excluded because of
insufficient data (n=1, also reported in
Supplement 1)

7 RCTs met inclusion criteria


(needle acupuncture n=6, laser acupuncture
n=1)

Fig. 1 – Flow chart of the trial selection process. TMD: temporomandibular joint disorder; UCT: uncontrolled clinical trial;
NRCT: non-randomized controlled clinical trial, and RCT: randomized clinical trial.
344
Table 1 – Summary of RCTs of acupuncture versus Sham acupuncture for TMD.
First author (year) Design/blinded Intervention Control group (regime) Main outcomes Intergroup AT method / Adverse event /
Randomized group (regime) differences acupoint/deqi risk of bias
Duration of TMD (week)
Types of TMD
Goddard (2002)29 2 parallel/DB (A) AT (30 min, (B) Sham AT (30 min once, (1) 100-mm VAS (1) P = 0.27, Fixed point/ n.r./Y,U,Y,Y,Y,U
18 once, n = 10) nonacupoint, penetrating (pain intensity) MD, 0.53 LI4, ST6/n.r.
>12 skin, 2–4 mm depth, n = 8) [ 1.48, 0.42]
Muscular

Smith (2007)31 2 parallel/DB (A) AT (20 min, (B) Sham AT (Park sham (1) 10-cm VAS (1) (A) MD;33.2 Fixed point/ST7/ n.r./Y,Y,Y,Y,Y,N
27 6 times for 3 needle, acupoint, non- (pain intensity) (B) MD;0.8a considered
weeks, n = 15) penetrating skin, 20 min (pre-post)
once, 6 times for 3

journal of dentistry 39 (2011) 341–350


weeks, n = 12)
>24 (2) MO (mm) (2) (A) MD; 3.2
(B) MD; 1.5a
(pre-post)
Combined (3) Muscle (3) P = 0.12,
tenderness RR, 4.801,35

Shen (2007)20 2 parallel/DB (A) AT (15 min, (B) Sham AT (1 cm distal to (1) 10-cm VAS (1) P = 0.06, Fixed point/ n.r./U,U,Y,Y,Y,Y
15 once, n = 9) LI4, non-penetrating, 15 min (pain intensity) MD, 1.09 LI4/n.r.
once, n = 6) [ 2.21, 0.04]
>12 (2) NRS (2) P = 0.22,
Muscular (facial pain) MD, 1.22
[ 3.16, 0.72]

Shen (2009)28 2 parallel/DB (A) AT (15 min, (B) Sham AT (1 cm distal to (1) 10-cm VAS (1) P = 0.24, Fixed point/ n.r./Y,U,Y,Y,Y,Y
28 once, n = 16) LI4, non-penetrating, 15 min (pain intensity) MD, 0.45 LI4/n.r.
once, n = 12) [ 1.21, 0.31]
n.r. (2) NRS (2) P = 0.84,
Muscular (facial pain) MD, 0.20
[ 2.14, 1.74]

Schmid-Schwap 2 parallel/DB (A) AT (20 min, (B) Sham laser (acupoint, (1) 100-mm VAS (1) P = 0.04, Fixed point/ no/U,Y,Y,Y,Y,Y
(2006)30 23 6 times for non-activated sham laser, (pain intensity) MD, 0.92 LI4, SI2,
3 weeks, n = 11) 20 min once, n = 12) [ 1.79, 0.05] SI3/n.r.
n.r. (2) MO (mm) (2) P = 0.10,
MD, 0.71
[ 0.14, 1.55]
Combined (3) Muscle (3) P = 0.002,
tenderness MD, 1.52
[ 2.47, 0.57]
journal of dentistry 39 (2011) 341–350 345

RR = relative risk; MD: mean difference; RCT: randomized clinical trial; n.r.: not report; Risk of bias: yes (Y): low risk of bias; No (N): high risk of bias; Unclear (U); DB: double blind, this means patient
AT: acupuncture; MO: mouth opening; TMD: temporomandibular joint disorder; VAS: visual analogue scale (100 mm scale); NRS: numeric rating scale (0–10 point, 11point scale); NS: non-significant;
n.r./U,U,Y,Y,N,U
n.r./Y,U,Y,Y,Y,Y

3. Results

3.1. Study description

The searches identified 491 potentially relevant studies, of


which 484 were excluded (Fig. 1). Of the excluded studies, 24
RCTs were excluded because they included other active
ST6, SI18, SI3,

treatments as controls instead of sham one, or because of


Fixed point/
SI2, SI3/n.r.
point/LI4,

scanty data.27 Those studies are separately summarized


LI4/n.r.

without explanation in Supplement 1. Finally, 7 RCTs met


Fixed

our inclusion criteria. The key data are summarized in Table 1.


Three trials originated from U.S.A.,20,28,29 two from
Austria,21,30 one from U.K.,31 and one from Germany.19
[ 1.18, 0.47]

[ 1.55, 0.14]

A total of 141 patients were included in these studies (mean


[0.13, 44.41]
(1) P = 0.40,

(2) P = 0.10,

(1) P = 0.52,

(2) P = 0.56,
[0.40, 1.58]
MD, 0.35

MD, 0.70

sample size: 20, female:male = 19.1:1, mean age: 37.3 years).


RR, 0.80

RR, 2.40

The diagnostic methods of TMD used were two trials29,31


diagnosed the subjects by Research diagnosed criteria (RDC/
TMD),2 the others did not report which diagnostic systems
were used.19–21,28,30 In all studies, for the types of TMD, five
(1) 100-mm VAS

(1) 100-mm VAS


(pain intensity)

(pain intensity)

(2) Verbal scale

studies were muscular type,19–21,28,29 none was articular type,


(pain free %)

and two were combined type of both.30,31 Six trials evaluated


tenderness
(2) Muscle

needle acupuncture,20,21,28–31 and one trial evaluated laser


acupuncture.19 The duration of TMD was generally more than
12 weeks. The duration of total treatment ranged from 1
treatment to 3 weeks (mean: 1.4 weeks). The subjective
times/week, 6 sessions, n = 3)

outcome measures of these trials were the VAS, numeric


non-activated sham laser,

non-activated sham laser,


1session = 15 min each, 2
(B) Sham laser (acupoint,

(B) Sham laser (acupoint,

rating scale (NRS), muscle tenderness (4 point scale) or verbal


scale (response rate of pain free) and an objective one was MO
(millimetre). The baseline comparison of TMD symptoms was
n.r., once, n = 12)

reported in five trials,20,21,28–30 but not in two.19,31


Outcomes cannot be estimated because this study does not provide standard deviation.

3.2. Description of acupuncture treatment

Of the 7 total studies, six studies comparatively tested needle


acupuncture against penetrating sham acupuncture,29 non-
penetrating sham acupuncture,20,28,31 or sham laser acupunc-
2 treatment/week,

ture,21,30 whilst the remaining study tested laser acupuncture


3 weeks, n = 4)
6 sessions for
15 min each,
once, n = 11)

(A) Laser AT

against sham laser acupuncture.19


(A) AT (n.r.,

A total of 6 acupuncture points were used (see Fig. 2). Of


them, LI 4 was used the most (34 times/total 91 points),
followed by SI 3 (19/91), ST 6 (13/91), SI 18 (12/91), SI 2 (7/91), and
ST 7 (6/91). Three of these 6 adopted acupoints were located in
the face, especially in the affected mandible (50%), whilst three
acupoints were in the hand (50%).

3.3. Adverse event


2 parallel/DB

2 parallel/DB

Only one RCT reported adverse event data of acupuncture and


Muscular

Muscular

sham acupuncture and this stated that there were no adverse


events.30 None of others mentioned adverse events.
n.r.

n.r.
23

3.4. Risk of bias in the included studies


and assessor-blind.
Katsoulis (2010)19

The methodological quality of the RCTs was variable. Four


Simma (2009)21

studies described an appropriate method of sequence genera-


tion.21,28,29,31 One used a random number table,29 and the others
used a computerized randomization method.21,28,31 The other
three studies did not clearly report how the allocation sequence
a

was generated. Allocation was concealed in two studies.30,31 All


346 journal of dentistry 39 (2011) 341–350
[()TD$FIG]

Fig. 2 – Acupuncture points used in included studies.

RCTs adopted both patient- and assessor-blinding and analysed 95% CI of 24.66 to 3.90, P = 0.007, heterogeneity: x2 = 1.42,
all participants without dropouts and withdrawals. Only two P = 0.70, I2 = 0%) (Fig. 3A2). Further subgroup analysis showed
studies reported details about the dropouts and withdra- acupuncture to be superior to non-penetrating sham control
wals.20,31 Five studies were considered quality in high (low risk methods in pain reduction by VAS in 4 studies (n = 89, WMD,
of bias)21,28–31 and two studies reported blinding but unclear 13.73; 95% CI of 21.78 to 5.67, P = 0.0008, heterogeneity:
randomization methods without appropriate allocation con- x2 = 1.45, P = 0.69, I2 = 0%).20,21,28,30 No significant difference was
cealment thus the quality of them was in moderate.19,20 In shown between acupuncture and a penetrating sham method in
addition, there was no publication bias because of symmetrical 1 study (n = 18, WMD, 12.95; 95% CI of 34.05 to 8.15, P = 0.23)
distribution by funnel-plot (data was not shown). (Fig. 3A3).29 Sensitivity analysis showed same results with above
meta-analysis regardless of study quality (data are not shown).
3.5. Outcomes Two RCTs were not pooled (though they used pain intensity
by VAS as an outcome measure) because of insufficient
3.5.1. VAS for pain intensity original data (no standard deviation),31 or dichotomous data
All seven RCTs reported the results of manual acupuncture instead of continuous data.19
contrasted with sham acupuncture in terms of pain intensity by
VAS.19–21,28–31 The point of time for measuring the VAS was 3.5.2. NRS for facial pain
referring to ‘now’ in six trials,20,21,28–31 that of the other one to Two RCTs20,28 reported on facial pain using NRS as pain
‘over last 14 days’.19 VAS scale on subjective pain in patients was measurement. Although they reported a more favourable
evaluated in same region in all studies, where were the main effect of needle acupuncture in the original article, our
area surrounding the TMJ, generally face, jaw and masseter recalculation showed no significant difference between real
muscle.19–21,28–31 The time for evaluating VAS scale was and sham groups (P = 0.30,20 P = 0.8428).
immediately after treatment in 6 studies,20,21,28–31 the other
one evaluated it after 16 weeks.19 Five trials showed favourable 3.5.3. Muscle tenderness
effects of acupuncture, whilst the others did not. The pooled Three RCTs21,30,31 assessed the effect of manual acupuncture
meta-analysis of data showed significant improvements in pain on muscle tenderness (4 point scale). All trials reported
intensity for VAS (5 studies, n = 107, WMD, 13.63; 95% CI of favourable effects of acupuncture. One of them could not be
21.16 to 6.10, P = 0.0004, heterogeneity: x2 = 1.46, P = 0.83, pooled in our meta-analysis, because of the scanty of the
I = 0%).20,21,28–30 A subgroup analysis of VAS for pain intensity by
2
original data (no standard deviation).31 A meta-analysis of
conditions showed favourable effects on real acupuncture these data also showed significant, favourable effects of
superior to sham acupuncture regardless of types of TMD; needle acupuncture (2 studies, n = 46, SMD, 1.08; 95% CI of
muscular type (4 studies, n = 84, WMD, 14.28; 95% CI of 24.66 1.88 to 0.28, P = 0.008, heterogeneity: x2 = 1.58, P = 0.21,
to 3.90, P = 0.007, heterogeneity: x2 = 1.42, P = 0.70, I2 = 0%), or I2 = 37%) (Fig. 3B).
combined type of TMD (1 study, n = 23, WMD, 12.90; 95% CI of
23.83 to 1.97, P = 0.02) (Fig. 3A1). By the number of treatments, 3.5.4. Mouth opening
included four RCTs that used only one-time acupuncture Two RCTs30,31 reported the effect of manual acupuncture on
treatment also showed favourable effects of acupuncture in maximum MO measured in millimetres. Although one RCT
pain intensity by VAS20,21,28,29 (4 studies, n = 84, WMD, 14.28; showed a favourable effect in the needle acupuncture group,
journal of dentistry 39 (2011) 341–350 347
[()TD$FIG]

Fig. 3 – Meta-analysis of acupuncture for TMD. VAS: visual analogue scale.


348 journal of dentistry 39 (2011) 341–350

this study did not provide a clear standard deviation.31 placebo is effective in masking patients, whether the patients
Therefore, no further pooled analysis was completed due to were informed or not.41 Therefore, these sham control
insufficient original data. Another RCT showed no statistical methods seem to have potential uses in double blind studies.
difference between real and sham groups.30 However, the success of blinding was not confirmed in the
included studies. Future trials should consider testing and
reporting the success of blinding. Blinding of the therapist
4. Discussion remains an unresolved problem in studies of acupuncture.
Recent studies show that the ‘‘style’’ of the acupuncturists
A total of 7 RCTs tested the effects of acupuncture compared to significantly impacts on the clinical outcome.42 It would
sham acupuncture.19–21,28–31 This systematic review produced therefore be important for future trials to find ways for
limited evidence that acupuncture is more effective than controlling for such confounding variables.
sham acupuncture in alleviating pain and masseter muscle The optimal duration and number of acupuncture treat-
tenderness in TMD. ments is an important clinical consideration.43 Four20,21,28,29 of
The methodological quality based on the Cochrane risk of the seven studies used only single acupuncture treatments to
bias is generally moderate. Although each RCT adopted test acute effects, whilst the other three19,30,31 studies adopted
assessor- and patient-blinding procedures, only four RCTs 6–12 acupuncture treatments. Regardless of the number of
used an appropriate sequence generation method.21,28,29,31 treatments, our meta-analysis of the pooled data showed
Only two RCTs employed allocation concealment.30,31 Trials superior effects of acupuncture. These results either indicate
with inadequate sequence generation cause selection bias.32 that acupuncture has a significant acute effect on TMD pain or
Only two RCTs reported details of dropouts and withdra- that the (non-blinded) acupuncturist’s ‘‘style’’ generates
wals.20,31 This may lead to exclusion or attrition bias.32 immediate effects (see above).
All included trials suffered from lack of sufficient sample Needle sensation (de-qi) was considered in one RCT,30 whilst
size without power analysis, therefore, they are susceptible to the other 6 trials did not report such details.19–21,28,29,31 None of
type II error.33 Small trials may also overestimate treatment the studies reported the stimulation and manipulation meth-
effects by about 30%.34 In our re-calculation of sample size ods. Recently, one f-MRI study reported that needle sensation
based on the mean difference value, at least 26 samples (in changed the brain response.44 Therefore, this seems to affect
each group) are needed for sufficient power (set at 80% power treatment outcomes. However, there was no significant
and 0.05 in alpha error).35 None were met this power. Clinically difference between groups whether the trial adopted de-qi or
significant changes of pain VAS in patients with muscular not. Hence, we do not know yet whether de-qi exerted an
TMD was suggested by 24.2 mm,36 also in general pain severity important influence on the clinical outcomes or not.
by 13–30 mm.37,38 Of included studies, the pain changes were A possible mechanism of acupuncture-mediated effects on
greater than 24.2 mm in two of included studies (one was TMD, based on an electromyographic (EMG) study, is that
30.2 mm29 and the other was 33.2 mm31), however, four of acupuncture causes the spinal cord and brain to release calming
them were smaller.20,21,28,30 Thus, the reliability of the agents such as serotonin, endorphins and neurotransmitters
evidence presented here is clearly limited. with anti-inflammatory action.45 In addition, after treatment
In this review, various sham control methods have been with acupuncture, a better distribution of EMG activity was
presented. The methods range from the use of a penetrating observed that indicated a greater muscular balance with the
needle on non-acupoints29 to non-penetrating needles on predominance of masseter muscles.45 However, none of these
acupoints19,21,30,31 or non-acupoints.20,28 ‘Real’ acupuncture effects have been independently confirmed.
was found to be superior to non-penetrating sham acupuncture Only one RCT addressed adverse events, but provided no
control in pain outcomes20,21,28,30 but showed no difference from details.30 The fact that most studies fail to mention adverse
penetrating sham acupuncture29 from our subgroup meta- effects is remarkable. Adverse effects of acupuncture are well
analysis. There are several possible explanations for these known and thus need to be considered in any clinical research.
findings; acupuncture might indeed be ineffective, alternatively, The lack of reporting of adverse effects seems to reflect the
penetrating sham control may have a similar effect to real one, often poor reporting of acupuncture trials. None of the
then the penetrating sham control may be invalid. Recently, one included trials reported ethical approval. This suggests the
study reported that a penetrating placebo needle could be need for an ethical review of acupuncture research.
considered as having a similar effect of acupuncture, because it is In conclusion, the evidence for acupuncture for TMD
not inert.39 management, especially for TMJ and masseter muscles pain, is
Furthermore, in another recent study,40 which was weak. Thus, this conclusion is clearly limited due to the small
reporting about relevance of non-penetrating sham acupunc- sample sizes and the small number of included RCTs.
ture, there was no significant difference in the correct Therefore, large-scale, rigorous studies with standardized
guessing of the real and sham acupuncture type amongst treatment method in high quality are needed to establish
blinded subjects. This may serve non-penetrating sham whether acupuncture has definite therapeutic value.
acupuncture as a credible sham control. However, for
confirming this, rigorous studies between 2 types of sham
are needed for overcoming the controversy. Acknowledgments
The double blind (i.e., blinding of the patient and the
evaluator) method was adopted in all of the trials. One study Byung-Cheul Shin was supported for two years by a Pusan
suggested that either a penetrating or non-penetrating needle National University Research Grant.
journal of dentistry 39 (2011) 341–350 349

Appendix A. Supplementary data 17. La Touche R, Angulo-Diaz-Parreno S, de-la-Hoz JL,


Fernandez-Carnero J, Ge HY, Linares MT, et al. Effectiveness
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Supplementary data associated with this article can be
disorders of muscular origin: a systematic review of the last
found, in the online version, at doi:10.1016/j.jdent.2011.02.006.
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Conflict of interest 18. La Touche R, Goddard G, De-la-Hoz JL, Wang K, Paris-
Alemany A, Angulo-Diaz-Parreno S, et al. Acupuncture in
the treatment of pain in temporomandibular disorders: a
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